FDA Adverse Event
Malfunction
Summary report: N
SWIFTSET
MDR report key: 19835885
·
Received July 26, 2024
Report
- Report Number
- 9617175-2024-00022
- Event Type
- Malfunction
- Date Received
- July 26, 2024
- Report Date
- July 26, 2024
- Manufacturer
- ADVANCED MEDICAL SOLUTIONS (PLYMOIUTH) LTD
- Product Code
- MPN
- PMA / PMN Number
- K122446
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS IS THE ONLY COMPLAINT FOR THIS DEFECT FOR THIS LOT AND HAS THEREFORE BEEN CONSIDERED TO BE AN ISOLATED INCIDENT AT THIS TIME, HOWEVER THE OCCURRENCE RATE SHALL BE MONITORED,
Description of Event or Problem · 0
ACCORDING TO THE REPORTER, IT WAS VERY LIQUID GLUE. WHEN APPLYING, TAKE MORE THAN 30 SECONDS TO DRY. RETURN OF PATIENTS DUE TO REOPENING OF THE PALATE (STITCHES NECESSARY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1528455 | SWIFTSET | TOPICAL SKIN ADHESIVE | MPN | ADVANCED MEDICAL SOLUTIONS (PLYMOIUTH) LTD | P00231561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |